Haloperidol

As a highly disabling severe mental disorder, rapid control of positive symptoms is the core goal of acute phase treatment for schizophrenia. Haloperidol is a first-generation typical butyrophenone antipsychotic drug, which exerts its effects by blocking central dopamine D2 receptors and α1 adrenergic receptors. It has definite efficacy on positive symptoms such as hallucinations, delusions, thought disorders and agitated behaviors. It is not only one of the first-line drugs for the acute phase of adult schizophrenia, but also can be used for the symptomatic treatment of Tourette syndrome and manic episodes in children. Meanwhile, its injection dosage form is often used for the emergency intervention of refractory psychomotor excitement.

In the global antipsychotic drug market, typical antipsychotic drugs have always occupied an important share in the primary medical care and the markets of low- and middle-income countries due to their outstanding cost performance and long clinical use cycle. In 2023, the global market size of haloperidol preparations was approximately USD 320 million, with a compound annual growth rate maintained at around 2.1%. In the domestic market, the annual procurement volume of public medical institutions exceeds 12 million boxes, and the price of preparations winning the centralized procurement bid has dropped to RMB 0.05 per tablet. The overall market pattern is dominated by generic drugs. More than 30 domestic enterprises currently hold preparation approval documents, and the localization rate of the API supply side has reached 94%.

The original developer of haloperidol is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, with the original brand name Haldol®. The core compound patent of this variety expired globally in 1980, and there is no core patent restriction at present. The main dosage forms approved for the original product include oral tablets (0.5mg, 1mg, 2mg, 5mg, 10mg, 20mg), injections (5mg/ml) and long-acting injections (50mg/ml, 100mg/ml). Among them, the common tablets and injections have been included in the Reference Listed Drug Catalog of the China Listed Drug Directory, and are also included in the FDA Reference Preparation Catalog. As of the retrieval time point, there are 22 haloperidol API registration entries on the domestic CDE API Registration Platform, of which 16 are in status A (approved for use in marketed preparations). A total of 41 haloperidol preparation varieties have been approved for marketing in China, covering two categories: tablets and injections. (Data as of December 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of haloperidol impurity reference standards. The products simultaneously meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities are in stock. Spot orders submitted before 16:00 can be shipped on the same day, which can fully meet the reference standard requirements for the whole process of API R&D, quality research and registration declaration.